When DH Relies on Another IRB

Commercial IRBs are independent, pay-per-service IRBs that conduct ethical and regulatory review for human subjects research.

• Ensures compliance with current and future regulatory requirements to use a single IRB review model for collaborative research.
• Improves time to approval since commercial IRBs meet frequently and can quickly approve studies while still complying with regulatory requirements.
• Enhances oversight as both the commercial IRB and DH have responsibility for ensuring compliance and safety of human participants.

All costs associated with review by a commercial IRB will be paid directly by the study sponsor and researchers will not be charged. IRB review fees are included in the clinical trials agreement for each study.

DH has agreements with Advarra, BRANY, and WCG, which are the commercial IRBs most commonly used by industry sponsors.

Beginning on December 15, 2023, all industry-sponsored studies for which DH is a participating site must use a commercial IRB.

Studies already approved by the DH IRB will not need to be submitted to a commercial IRB and will remain under DH's oversight.

An application for review by an external (commercial) IRB must be submitted via eIRB. This application asks only for that information needed for Human Research Protection (HRPP) staff to ensure institutional requirements are met.

Know that other DH offices might be needed to ensure that all institutional policies and local context concerns are met.

When the DH IRB relies on the review of an external (commercial) IRB, we are required to identify, interpret and communicate to the external (commercial) IRB, the requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local ancillary reviews, restrictions on use and disclosure of PHI, training requirements, and the like. While the DH IRB will collect this information, these reviews are completed by a DH office, other than the DH IRB.

An application to be added as a site to a collaborative industry-sponsored study must be submitted to the commercial IRB reviewing the study. This is a brief application process and provides DH study teams with approved consent and other study documents. Initial training on how to use their submission systems will be provided by the commercial IRBs. Following, recordings of these trainings will be available on the DH IRB website. You can also check the commercial IRBs website for more training information.

Institutional requirements such as conflict of interest reporting and human subjects research training still apply to studies reviewed by an external IRB. HRPP staff will review applications to rely on a commercial IRB to ensure these requirements are met.

• For questions about DH requirements and processes, contact the IRB Office.
• For questions about a commercial IRB's process and submission system, contact the commercial IRB that you are working with. The DH IRB provides resource material and additional information from Advarra, BRANY, and WCG.